Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

NCT03521505 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201601093A3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Preventing hypoxemia is one of the major goal of studies for bronchoscopic sedation. Dexmedetomidine is a sedative agents via α2 adrenergic agonist, with little respiratory suppression. In the preset study, we evaluate the safety and feasibility of the Dexmedetomidine in the specific bronchoscopic procedure, endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration.

Conditions

Bronchoscopy

Keywords

Sedation; dexmedetomidine; brain perfusion; bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Hypoxemia During Maintenance

  The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)\<90%) during maintenance of Bronchoscopic sedation

  After starting bronchoscopy, up to 120 minutes

Secondary Outcomes (6)

• Hypoxemia During Induction

  After starting induction, up to 30 minutes.

• The Global Tolerance for Bronchoscopy

  After recovery from sedation, up to 120 minutes

• The Cooperation of Patients From the View of Bronchoscopists

  After recovery from sedation, up to 120 minutes

• Hypotension During Bronchoscopic Sedation

  After starting sedation, up to 120 minutes.

• Bradycardia During Bronchoscopic Sedation

  After starting sedation, up to 120 minutes.

Study Arms (2)

Dexmedetomidine arm

EXPERIMENTAL

Dexmedetomidine will be administrated for sedation of EBUS-TBNA

Drug: Dexmedetomidine arm

Propofol arm

ACTIVE COMPARATOR

Propofol will be administrated for sedation of EBUS-TBNA

Drug: Propofol arm

Interventions

Dexmedetomidine arm DRUG

Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5\~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3\~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 \< 90%) or hypotension (mean arterial pressure (MAP) \< 65 mmHg, or systolic blood pressure (SBP) \< 90 mmHg) in any duration

Dexmedetomidine arm

Propofol arm DRUG

5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3\~2. Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 \< 90%) or hypotension (mean arterial pressure (MAP) \< 65 mmHg, or systolic blood pressure (SBP) \< 90 mmHg) in any duration.

Propofol arm

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective bronchoscopy and sedation

You may not qualify if:

• Age less than 20 years
• American Society of Anaesthesiologists (ASA) physical status classification IV or V
• Mallampati score of 4
• Severe sleep apnoea syndrome (apnoea-hypopnea index more than 40)
• Body mass index more than 42 in males or 35 in females
• Neurologic disorders or other conditions contributing to difficulty in assessing response
• Forced expiratory vital capacity (FVC) less than 15 ml/kg body weight, forced expiratory volume in one second (FEV1) less than 1000 ml, or FEV1/FVC less than 35%
• History of second or third degree atrioventricular block, heat rate less than 50 beat per minute or systolic blood pressure less than 90 mmHg
• Pregnancy
• Patients with a known history of allergy to the study drugs, or to eggs, soybeans or sulfite products

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (5)

• Lin TY, Lo YL, Hsieh CH, Ni YL, Wang TY, Lin HC, Wang CH, Yu CT, Kuo HP. The potential regimen of target-controlled infusion of propofol in flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2013 Apr 24;8(4):e62744. doi: 10.1371/journal.pone.0062744. Print 2013.

  PMID: 23638141 BACKGROUND

• Lo YL, Lin TY, Fang YF, Wang TY, Chen HC, Chou CL, Chung FT, Kuo CH, Feng PH, Liu CY, Kuo HP. Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2011;6(11):e27769. doi: 10.1371/journal.pone.0027769. Epub 2011 Nov 23.

  PMID: 22132138 BACKGROUND

• Lin TY, Fang YF, Huang SH, Wang TY, Kuo CH, Wu HT, Kuo HP, Lo YL. Capnography monitoring the hypoventilation during the induction of bronchoscopic sedation: A randomized controlled trial. Sci Rep. 2017 Aug 17;7(1):8685. doi: 10.1038/s41598-017-09082-8.

  PMID: 28819181 BACKGROUND

• Ryu JH, Lee SW, Lee JH, Lee EH, Do SH, Kim CS. Randomized double-blind study of remifentanil and dexmedetomidine for flexible bronchoscopy. Br J Anaesth. 2012 Mar;108(3):503-11. doi: 10.1093/bja/aer400. Epub 2011 Dec 15.

  PMID: 22174346 BACKGROUND

• Lin TY, Huang YC, Kuo CH, Chung FT, Lin YT, Wang TY, Lin SM, Lo YL. Dexmedetomidine sedation for endobronchial ultrasound-guided transbronchial needle aspiration, a randomised controlled trial. ERJ Open Res. 2020 Nov 10;6(4):00064-2020. doi: 10.1183/23120541.00064-2020. eCollection 2020 Oct.

  PMID: 33693047 RESULT

Results Point of Contact

• Title: Dr Ting-Yu Lin
• Organization: Chang-Gung Memorial Hospital

yuebaoyuebao@gmail.com

886 3281200

Study Officials

• Ting-Yu Lin, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Assistant professor

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 11, 2018
• Study Start: May 11, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: September 9, 2021
• Results First Posted: September 9, 2021

Record last verified: 2021-08

Locations

TW (1)